MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-07 for CMF CUSTOMIZED IMPLANT KIT LARGE 5444-0-300 manufactured by Stryker Orthopaedics-mahwah.
[185730081]
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[185730082]
It was reported that post-op a patient presented with a csf leak and a revision surgery was performed. During the revision, it was noticed that the pmma customized implant had cracked. The implant was removed, re-positioned and re-implanted. The doctor was happy with the fit. There are no post-op scans from either procedure to reference. Update 16/december/2019: as reported in the communication log: the sales rep spoke to dr. And she believes the crack was due to trauma. The surgery was to repair a csf leak and while making the exposure, they noticed the crack. She suspects the two, crack and csf leak, were related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00043 |
| MDR Report Key | 9560312 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2019-12-10 |
| Device Manufacturer Date | 2019-04-17 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. COLLIN NEITZEL |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CMF CUSTOMIZED IMPLANT KIT LARGE |
| Generic Name | MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCT |
| Product Code | KKY |
| Date Received | 2020-01-07 |
| Catalog Number | 5444-0-300 |
| Lot Number | 1903041019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-07 |